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ACSS - NCE work-sharing pilot

Australia-Canada-Singapore-Switzerland (ACSS) Consortium

11 September 2018
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The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore's Health Sciences Authority (HSA) and the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland. Regulatory authorities face very similar challenges, such as increasing workload and increasing complexities in the medicinal applications that are being regulated, thus contributing to increasing pressure on available resources. The purpose of the consortium is to build synergies and share knowledge amongst the regulatory authorities thereby enhanced efficiency of regulatory systems.

The ACSS Consortium consists of several working groups with various objectives and projects that aim to help meet the challenges faced by regulatory authorities, including timely access to safe therapeutic products within a limited resource capacity. The working groups use a network of bilateral confidentiality agreements and Memoranda of Understanding to conduct their work.

The New Chemical Entities (NCE) Working Group was formed to focus on developing opportunities within regulatory program through the greater alignment of regulatory approaches and technical requirements. With this in mind, the NCE Working Group has launched an innovative work sharing pilot for the coordinated assessment of a NCE application that has been filed within two jurisdictions. The pilot will work through the practicalities of undertaking a coordinated assessment that will complement the regulatory decision-making within each jurisdiction.

ACSS NCE work-sharing pilot

THE ACSS NCE work-sharing pilot is a truly unique global collaboration between regulatory authorities and the pharmaceutical industry. The valuable knowledge and experience obtained through this pilot exercise will inform internal procedures on the effective use of international assessment reports.

Further benefits for the pharmaceutical industry could include a reduction in regulatory burden (e.g., with the filing of common dossiers), timely regulatory decisions, concurrent market authorisation decisions, and the opportunity to contribute to advancing regulatory innovation.

The ACSS NCE working group is actively exploring opportunities for work sharing with industry, and is seeking applications for this pilot via the downloadable 'Expression of Interest' form. To be a suitable candidate for this work-sharing pilot, applications should be submitted simultaneously to at least two, of the ACSS Consortium members. Initially, the ACSS NCE working group will focus on common submissions between Health Canada and Therapeutic Goods Administration, while ACSS NCE working group builds confidence and experience in this innovative pilot. In general, each regulator will evaluate their respective Module 1; Health Canada and TGA will evaluate Module 3 (Quality) and Module 4 (Toxicology) respectively, and both regulators will separately evaluate Module 5 (Clinical). With experience, the ACSS NCE work-sharing pilot will look to extend work-sharing opportunities to include Singapore and Switzerland.

During the pilot, regulators will work through the practicalities of undertaking a single assessment that will support regulatory decision-making within each jurisdiction in accordance with ACSS respective regulatory requirements.

It is preferable that Modules 2-5 of the application contain common information. However, any differences in Modules 2-5 should be clearly identified by the applicant (e.g., using the template provided within the Expression of Interest form for summarizing any differences). In addition, the application submitted to each of the identified regulatory authorities would include the country-specific Module 1 for the respective agency.

Next steps

ACSS NCE working group are inviting applicants interested in participating in this innovative work sharing pilot to contact your regional regulatory authority:

Communications via email should include 'ACSS Consortium - NCE pilot' in the subject line.

Interest from other ACSS regulators is also encouraged to enable workflow mapping.

Q&A

Useful links

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Contact information

Email: streamlinedsubmission@health.gov.au